Former Biggest Loser star Jillian Michaels may turn out to be a big loser herself. Since leaving the television program, the fitness trainer with a signature line of plant-extract-containing weight-loss pills has had to defend herself against three class-actions lawsuits.
Two of the plaintiffs allege that the product Michaels has been peddling is worthless. The third claims that the folk remedy contains toxic levels of citrus aurantium, an herbal stimulant that can induce high blood pressure and cardiac symptoms. The FDA says citrus aurantium has clinical effects similar to those of ephedra, another natural stimulant, which was banned in 2004.
Michaels’ concoction is just one of many dubious and potentially life-threatening herbal remedies on the market today. Faced with myriad dietary supplements available over the counter in supermarkets, pharmacies, and big-box stores, many people assume that these pseudomedications carry some government seal of approval, but nothing could be farther from the truth.
Many herbal products are complex, highly variable, and impure. Not unlike the nineteenth-century snake-oil preparations that were dangerous but had little (if any) efficacy, many are toxic, carcinogenic, or otherwise unsafe. Known side effects include blood-clotting abnormalities, hypertension, deadly allergic reactions, irregular heart rhythms, kidney and liver failure, exacerbation of autoimmune diseases, and interference with lifesaving prescription drugs. A case in point is St. John’s wort, a commonly used herbal supplement that is moderately effective as an antidepressant but that interacts adversely with dozens of prescription drugs. Its life-threatening side effects include rejection of heart transplants, caused by an interaction with the immunosuppressant cyclosporine, and treatment failure in AIDS patients because of interference with the protease inhibitor indinavir.
Potentially harmful interactions with “real” drugs become exponentially more difficult to predict as the number of medications (and pseudomedications) increases. The American Society of Anesthesiologists has warned patients to stop taking herbal supplements at least two weeks before surgery to avoid dangerous interactions with anesthesia.
Why aren’t these products regulated?
Congress virtually exempted them from oversight under a 1994 law that bars federal authorities from requiring that herbal remedies be safe or effective, or even that dosage information on the label is correct. Moreover, in 1999 the FDA freed manufacturers to make all sorts of dubious health claims—that their products treat conditions such as premenstrual syndrome and acne, for example, even though few have been shown to be efficacious for anything. (And none is as effective as a “real” drug.)
As the body count from herbal remedies mounts, Congress is finally taking some tentative steps to protect the public. Senator John McCain of Arizona and a bipartisan group of four other senators have introduced legislation that would
- Require all dietary supplement makers to register with the FDA;
- Empower the FDA to issue “a mandatory recall order” if there is a reasonable likelihood that a supplement is spiked with a harmful substance or could otherwise cause serious health problems;
- Encourage the FDA to publish new guidelines on dietary supplement ingredients;
- Require the FDA to notify the Drug Enforcement Administration if it finds that a dietary supplement contains a steroid.
The proposed legislation is good, as far as it goes. The provision to register supplement makers is important because the FDA lacks reliable information about how many supplement makers exist, where they are located, and the range of products they’re peddling, let alone what ingredients they’re using, according to a recent Government Accountability Office report.
The FDA should also be empowered to publish a prescriptive list of supplement ingredients from which manufacturers could not deviate except to allow a reasonable margin for harmless impurities. Some ingredients, such as citrus aurantium, are so dangerous and of such low therapeutic value that they should join ephedra on the list of banned substances. And because of its interference with so many “real” drugs, St. John’s wort is another candidate for this category.
Congress should also require manufacturers to have their supplements analyzed by an independent, nongovernmental entity to ensure that the label on the bottle accurately reflects both the ingredients and the number of dosages. A model is the Nationally Recognized Testing Laboratories—the prototype of which is Underwriters Laboratories, a large nonprofit organization that tests and certifies more than 20,000 categories of products ranging from lighting fixtures and surge protectors to bulletproof glass.
Adoption of McCain’s legislation and our proposals would still leave unaddressed the lack of assurance of efficacy, but it would offer consumers a modicum of protection against deficient manufacturing practices and outright fraud while letting them choose among a wide spectrum of competing products. Without these basic safeguards, patients will continue to be exposed to unacceptable risks but without much likelihood of benefit.